Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has entered into a worldwide collaboration and licensing agreement with Cellular Biomedicine Group (CBMG) for a pair of CAR T-cell therapy candidates.

Under the terms of the agreement, Janssen will pay CBMG an upfront fee of $245m, with the Chinese biotech also eligible for certain milestone payments, as well as tiered royalties.

In exchange, CBMG will grant Janssen a worldwide licence to develop and commercialise the CAR-T assets, excluding Greater China, with the companies set to negotiate an option for the pharma to commercialise the products in the China territory.

The investigational CAR-Ts have shown promising early-stage results in patients with relapsed/refractory non-Hodgkin’s lymphoma, the companies said, with the majority of these patients having diffuse large B-cell lymphoma (DLBCL).

DLBCL is characterised by the uncontrolled rapid growth of a type of immune cell called lymphocytes, with CD20 and CD19 antigens commonly found on the surface of the cells.

One of CBMG’s therapies, C-CAR039, targets both CD19 and CD20 antigens and is being assessed in a phase 1b study in the US in relapsed or refractory DLBCL.

The second candidate, C-CAR066, targets CD20 and has a similar phase 1b study due to begin later this year.

Sanofi has signed an exclusive worldwide licensing agreement with Maze Therapeutics for its glycogen synthase 1 (GYS1) programme, including a lead candidate for Pompe disease and other glycogen storage disorders.

Under the terms of the deal, Sanofi will pay the Californian biotech $150m in upfront cash and equity, with Maze also eligible for an additional $600m in potential development, regulatory and sales milestones plus royalties.

In exchange, Sanofi will gain the rights to further develop and commercialise MZE001 and have an exclusive licence to related GYS1-targeting back-up programmes and intellectual property.

Pompe disease is a rare genetic disorder that causes progressive weakness to the heart and skeletal muscles.

The condition is caused by mutations in the gene coding for acid alpha-glucosidase (GAA), which the body uses to break down glycogen.

MZE001, designed and developed by Maze, is an oral GYS1 inhibitor that aims to address Pompe disease by limiting glycogen accumulation.

The candidate has recently cleared its first phase 1 clinical trial, with phase 2 development due to start later this year.

Earlier this year, Sanofi announced that its long-term enzyme replacement therapy will now be available on the NHS to patients with Pompe disease, following a recommendation from the National Institute for Health and Care Excellence in 2022.

Eli Lilly’s experimental Alzheimer’s drug, donanemab, has been shown to significantly slow cognitive and functional decline in patients with early-stage disease.

The phase 3 TRAILBLAZER-ALZ 2 study met its primary endpoint, with the drug slowing the progression of the disease by 35% compared to placebo in 1,182 patients with early symptomatic Alzheimer’s disease and intermediate levels of tau protein.

All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits, the company said.

Results from the trial demonstrated that 47% of patients who received donanemab showed no disease progression a year after starting treatment, compared with 29% in the placebo group.

Additionally, 52% of donanemab-treated patients completed their course of treatment by one year, and 72% completed by 18 months as a result of achieving amyloid plaque clearance.

Patients receiving donanemab also experienced a 39% lower risk of progressing to the next stage of disease, and those in the treatment group had 40% less decline in their ability to perform activities of daily living at 18 months.

Based on these results, Lilly said the company will proceed with global regulatory submissions “as quickly as possible”.

Roche has announced positive new data from a mid-stage study of fenebrutinib in adults with relapsing forms of multiple sclerosis (MS).

The phase 2 FENopta study met its primary and secondary endpoints, the company said, with oral fenebrutinib significantly reducing MRI markers of MS disease activity in the brain compared to placebo.

MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The disease affects approximately 2.8 million people worldwide.

Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods.  Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% of patients who are diagnosed with progressive forms of the disease.

Roche and Genentech’s fenebrutinib belongs to a class of drugs known as Bruton’s tyrosine kinase (BTK) inhibitors, which work by selectively blocking the cells that drive the autoimmune reaction behind MS.

Fenebrutinib is a dual inhibitor of both B-cell and microglia activation, which Roche says “has the potential to reduce both MS disease activity and progression”.